NCT02060487

Effects of Oral Sildenafil on Mortality in Adults With PAH

A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day \[TID\]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	sildenafil citrate	sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
DRUG	sildenafil citrate	sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
DRUG	sildenafil citrate	sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study

Timeline

• Start date: 2014-09-22
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2014-02-12
• Last updated: 2022-05-13
• Results posted: 2022-05-10

Locations

82 sites across 23 countries: United States, Australia, Belgium, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece, Hong Kong, Israel, Latvia, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Singapore, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study